标准编号：ISO/TR 20416:2020
中文名称：医疗设备 制造商的上市后监测
英文名称：Medical devices — Post-market surveillance for manufacturers
发布日期：2020-07
标准范围
This document provides guidance on the post-market surveillance process and is intended for use
by medical device manufacturers. This post-market surveillance process is consistent with relevant
international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive
and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. The output of this process can be used:
— as input into product realization;
— as input into risk management;
— for monitoring and maintaining product requirements;
— for communicating to regulatory authorities; or
— as input into improvement processes.
This document does not address market surveillance activities to be performed by regulatory
authorities. Neither does it specify a manufacturer’s actions required by the applicable regulatory
requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.
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